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510(k) Data Aggregation
(34 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Free Vinyl Synthetic Exam Gloves White Color." This document primarily addresses the substantial equivalence determination for a medical device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications, as would typically be found in a study report or clinical trial documentation.
Therefore, I cannot provide the requested information based solely on the input provided. The document confirms the device's classification and allows its marketing but does not detail the technical performance or the studies behind it.
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(49 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
The provided text is a 510(k) summary letter from the FDA to Synmertex Company Limited regarding their Disposable Powder Free Vinyl Synthetic Examination Gloves. This letter does not describe acceptance criteria for a device, nor does it detail a study proving device performance based on such criteria. Instead, it is an FDA clearance letter, indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information from the given text.
The document discusses:
- Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color
- Regulation Number & Product Code: 880.6250, LYZ (Patient Examination Glove, Class I)
- Indications For Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner."
- FDA Clearance: The letter states the device is "substantially equivalent" to predicate devices.
This type of FDA letter confirms market clearance, but it does not include detailed performance studies, acceptance criteria, or ground truth methodologies that would be typical for many medical devices, especially those involving AI or more complex functionalities. For examination gloves, performance is usually assessed against established ASTM (American Society for Testing and Materials) standards (e.g., for barrier integrity, tensile strength), but these details are not present in this FDA clearance letter.
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(35 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color." It primarily addresses the substantial equivalence determination for the device. As such, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be associated with a study demonstrating a device meets acceptance criteria for an AI/CAD system.
The document is for a Class I medical device (patient examination gloves), which typically has much simpler regulatory requirements than more complex devices and certainly does not involve AI or sophisticated image analysis.
Therefore, I cannot provide the requested information from the given text. The provided text does not describe a study that proves a device meets acceptance criteria in the way you've outlined for an AI/CAD system.
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